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October 2026 allergy news: FDA approvals for berotralstat pellets and remibrutinib, RAPIDe-3 data in HAE, alpha-gal syndrome, and Viaskin Peanut Patch.
October brought 2 US Food & Administration (FDA) approvals to allergy and immunology. The agency approved a 150 mg oral pellet formulation of berotralstat (Orladeyo) for hereditary angioedema (HAE) prophylaxis in patients aged ≥ 12 years and remibrutinib (Rhapsido) as the first therapy specifically for symptomatic dermographism.
Phase 3 RAPIDe-3 results for oral deucrictibant appeared in The Lancet, and HCPLive examined where the Viaskin Peanut Patch would fit after a Biologics License Application (BLA) submission. Coverage also included alpha-gal syndrome (AGS) diagnostic delays, infant anaphylaxis management, and benign delayed penicillin reactions in early childhood. Here are 7 allergy headlines you may have missed.
The FDA approved a 150 mg oral pellet formulation of once-daily berotralstat (Orladeyo, BioCryst Pharmaceuticals) for prophylaxis of HAE attacks in patients aged ≥ 12 years, BioCryst announced on October 21, 2026. The pellets offer an alternative for patients who have difficulty swallowing or prefer not to take capsules, and they allow patients who began pellets before age 12 years to remain on the formulation.
The decision rested on chemistry, manufacturing, and controls information, along with safety and tolerability data comparing pellets with capsules. BioCryst did not report new efficacy data for the pellets. In 2 capsule studies, berotralstat 150 mg produced a mean 91% reduction in attack rate at 96 weeks, according to the company.
The FDA approved remibrutinib (Rhapsido, Novartis) for adults with symptomatic dermographism inadequately controlled by H1 antihistamines, making the oral Bruton tyrosine kinase inhibitor the first therapy approved specifically for the condition, according to Novartis. The indication expands remibrutinib beyond chronic spontaneous urticaria at the same 25 mg twice-daily dose.
In the phase 3 RemIND trial, 29.3% (17/58) of patients receiving remibrutinib achieved a complete Total Fric Score response at week 12 vs 14.0% (8/57) with placebo (P =.0229).
Oral deucrictibant produced faster symptom relief than placebo for on-demand treatment of HAE attacks in the phase 3 RAPIDe-3 trial, published October 8, 2026, in The Lancet. Median time to onset of symptom relief was 1.28 hours with a 20 mg immediate-release capsule vs > 12 hours with placebo among 88 participants with paired treated attacks (P <.0001).
The randomized, double-blind, placebo-controlled crossover trial met all 11 secondary endpoints. Pharvaris reported a Prescription Drug User Fee Act target action date of April 23, 2027, for the bradykinin B2 receptor antagonist.
As the lone star tick becomes established on Long Island and in Massachusetts, AGS is reaching regions where many clinicians have little experience with it. HCPLive's feature examines why delayed reactions and gastrointestinal-only symptoms can leave patients undiagnosed for months or years, with perspectives from Chirag Patel, MD, of Hackensack Meridian Health; Shaun Cross, PhD, of the University of Nebraska Medical Center; and Benjamin W. Casterline, MD, PhD, of the University of Missouri School of Medicine.
In a 2022 CDC survey of 1,500 health care providers, 42% had never heard of AGS.
Related: Alpha-Gal Syndrome Clues Clinicians Miss, With Chirag Patel, MD. Patel discusses reaction timing, isolated abdominal pain, and alpha-gal IgE test interpretation.
DBV Technologies submitted a BLA to the FDA on September 29, 2026, for the Viaskin Peanut Patch in children aged 4 to 7 years with peanut allergy and requested Priority Review. The filing came 2 months after the discontinuation of Palforzia (peanut allergen powder-dnfp), the only FDA-approved oral immunotherapy (OIT) for peanut allergy.
HCPLive's FAQ compares the investigational patch with omalizumab (Xolair) and office-based OIT by age, delivery, foods covered, efficacy data, and trade-offs.
Anaphylaxis in infants and toddlers presenting to a pediatric emergency department was predominantly food-triggered and tended to resolve after a single intramuscular epinephrine dose, according to a retrospective cohort study in Pediatric Emergency Care. Investigators analyzed 155 patients aged 0 to 24 months seen from June 2019 to June 2022.
Food triggered 96.1% (149/155) of episodes, and skin and mucosal symptoms occurred in 99.4% of patients. Intramuscular epinephrine was administered to 87.1% of patients, 90.4% of whom received a single dose. Most patients (88.4%) were discharged home, and no admitted patient required additional epinephrine after admission.
Benign delayed penicillin hypersensitivity in early childhood was associated with a modest increase in later immune-mediated disease in a nationwide Israeli cohort of 1,375,537 children, according to a research letter in Annals of Allergy, Asthma & Immunology. The composite outcome occurred in 6.2% of children with a benign delayed reaction vs 5.4% of those without, and the association persisted after adjustment for prior health care utilization (OR, 1.08; 95% CI, 1.03–1.13). The strongest remaining signals were autoimmune cytopenias and Henoch-Schönlein purpura.
Eyal Kristal, MD, of Saban Children's Hospital at Soroka University Medical Center, described the finding as an epidemiological signal requiring no clinical steps and advised clinicians to continue penicillin allergy de-labeling.